QualiMetrix Analytical Development Services for Pharmaceuticals

QualiMetrix provides integrated analytical services and product development for the pharmaceutical industry.

The company offers support throughout formula development, product registration and post-marketing stages, while its analytical offerings include quality control (QC) testing and research and development (R&D) studies. All of company’s studies are performed using state-of-the-art instrumentation that is consistently updated.

QualiMetrix’s contract laboratory meets the stringent regulatory requirements of the healthcare industry, performing consistently to good manufacturing practice (GMP) and good laboratory practice (GLP) standards.

Analytical and pharmaceutical development services

QualiMetrix supports the development and optimisation of pharmaceutical composition, manufacturing processes and specifications.

The company also provides an integrated package of development and analytical method validation. In premised there is under operation a wide range of analytical instrumentation, which covers any pharmacopoeia or non-pharmacopoeia test, including high-performance liquid chromatography (HPLC), ultra-high-performance liquid chromatography (UPLC), head space gas chromatography  (GC), dissolution apparatus I-IV, tandem mass spectrometry (MS/MS) triple quadrupole, ion trap-orbitrap and inductively coupled plasma mass spectrometry (ICP-MS).

Batch testing and release for API and final products

QualiMetrix performs testing and releasing of active pharmaceutical ingredients (API), excipients, packaging and final products, which include all pharmaceutical forms and high-potent drugs

Stability and photostability studies meeting ICH guidelines

QualiMetrix’s comprehensive stability testing services are conducted according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

Its stability study protocols meet quality procedures and GMP requirements and are available for all climatic zones from I to IVb.

The chambers are temperature and humidity controlled and are connected to a 24-hour alarm system. Photostability testing is based on fluorescent light source under controlled conditions according to option 2 of the ICH Q1B guideline.

Scientific guidance is provided for the study design (such as full design, bracketing, matching and reduced design), as well as to the statistical evaluation of the stability data.

Leachables and extractables studies for packaging and manufacturing materials

Polymeric and elastomeric materials are commonly encountered during the manufacturing process of pharmaceutical products and components of the packaging / container closure system.

During the product’s expected shelf-life and use, the constant contact and stressing may bring about a change in the composition of the product stored through interactions with its packaging.

Product packaging interaction studies focus on establishing this change in the product composition brought about by the interplay of packaging and stored content through means of molecular exchange. This exchange involves the solubilisation of compounds within the polymeric or metal matrix and their subsequent migration into the bulk of the stored product.

Elemental impurities according to Q3D guideline

Following the Q3D Guideline related to the control of the elemental impurities, QualiMetrix can provide a complete risk assessment, method development, validation and sample analysis for the determination of elemental impurities in final products and API by ICP-MS.

Filter validation studies

In accordance with the Parenteral Drug Association (PDA) technical report No 26/2008, QualiMetrix undertakes filterability, compatibility, and filter extractables tests, as well as bacterial challenge and viability tests as part of the filter validation activity.

In-vitro release testing and permeation studies

QualiMetrix performs in-vitro release (IVR) testing for semisolid preparations according to the provisions of USP General Chapter <1724> Semisolid Drug Products Performance Tests by using Franz diffusion cell, as well as in-vitro permeation (IVP) studies with human skin by following robust and discriminating analytical methodology.

Reverse engineering studies

QualiMetrix’s reverse engineering studies determine the composition of a reference pharmaceutical product to develop an essentially similar product.

Reliable and accurate determination of excipients is performed and a quantitative product composition is provided.

Identification of unknown impurities

QualiMetrix provides structural elucidation of unknown compounds using accurate mass measurements through high-resolving power mass analysers (HRMS) that that leads to the highest confidence of the proposed structure.

Toxicological evaluation

The toxicological evaluation is performed with in-silico methodologies such as DEREK NEXUS software. The study is based on scientific literature and bacterial reverse mutation tests.

Scientific advice

QualiMetrix provides high-quality reports, regulatory consultations, data gap analysis, scientific advice relating to the European Medicines Agency (EMA) or national agencies, and a letter of deficiencies response.

About QualiMetrix

Qualiemtrix is a customer-driven laboratory that employs the Six Sigma philosophy to design and implement optimised processes with the aim of transforming customer inputs and requirements into customer value.

As such, the first and probably the most critical factor for a successful project is its proper definition in terms of both customer and technical requirements. To this end, a comprehensive study request form is provided to the customer with the following objectives:

  • The definition of the type and scope of the study
  • The provision of critical product information
  • The determination of the most suitable, expedient and cost-effective approach

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White Papers

Leachables and Extractables in Pharmaceuticals

Extractables are organic and inorganic chemical entities that can be released from a test article and into an extraction solvent under laboratory conditions.

Address
Qualimetrix S.A.

579 Mesogeion Ave.,

15343, Agia Paraskevi,

Athens

Greece

+30 210 608 7000 +30 210 608 7012 (Business Development Manager) www.qualimetrix.gr

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Regional Offices

Qualimetrix S.A.

579 Mesogeion Ave.,

15343, Agia Paraskevi,

Athens

Greece

Mrs Maria Mastrogiannopoulou - Business Development Manager +30 210 608 7000 +30 210 608 7012 (Business Development Manager) www.qualimetrix.gr

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